Reported May 29, 2019 · Terminated
Amitiza (lubiprostone) capsules, 8 mcg, 60-count bottle, Rx only, Manufactured by: Sucampo Pharma Americas, LLC, NDC…
Mallinckrodt Pharmaceuticals
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: MALLINCKRODT PHARMACEUTICALS · 1425 Us Highway 206 · Bedminster, NJ · 07921-2653
Is this the product you have?
- Amitiza (lubiprostone) capsules, 8 mcg, 60-count bottle, Rx only
- Manufactured bySucampo Pharma Americas, LLC, NDC 64764-080-60
- Lot codes and dates
Lot #: 3229691-61Exp 01/2022
- Amount recalled
- 89,808 bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Labeling: Label mix-up. Amitiza 8 mcg capsules are being recalled because 24 mcg capsules were found in a 8 mcg trade 60 ct. bottle. Amitiza 24 mcg capsules are being recalled because a sealed 60 ct. bottle contained only 8 mcg capsules, this incident is being considered as a labeling mix-up issue.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Mallinckrodt Pharmaceuticals recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.